1. When to arrange an audit

Manufacturers applying for a licence to manufacture veterinary chemical products in Australia must arrange and undergo an audit as part of the licence application process, unless they already hold evidence from a recognised body.

Manufacturers may also request or be required to have a ‘partial’ audit between scheduled dates, meaning only certain aspects of the site or process are inspected. Partial audits are most often requested when the manufacturer is applying to the APVMA to vary their licence to extend its scope.

Certain overseas manufacturers will need to arrange an audit of their site prior submitting an application to register a product. Overseas manufacturers audited by the APVMA are then required to organise audits according to the schedule set by the APVMA to ensure ongoing compliance of GMP throughout the life of the product’s registration.

2. Selecting and engaging an auditor

The APVMA publishes a list of APVMA-authorised auditors. Generally, manufacturers may select their own auditor from the list, however, the APVMA reserves the right to participate in the audit or to reject the manufacturer’s choice and nominate an auditor it considers to be appropriate.

Unless given prior approval by the APVMA, manufacturers must only engage auditors who:

do not have a financial interest in them

have not previously been in their employ

have not provided consultancy services to them in the past three years

Manufacturers can contact their selected auditor directly from the list and arrange for the audit to be conducted at a suitable time within the assigned audit schedule. After booking the auditor, the manufacturer is responsible for notifying the APVMA.

3. Audit charges

Audit charges vary depending on the duration of the audit, the complexity of the manufacturing premises, the category of manufacture, the travel required and the APVMA-authorised auditor’s own fee schedule.

APVMA-authorised auditors are not employees of the APVMA, they are independent businesses and consultants. This means the auditor, not the APVMA, determines the audit charges, provides a quote and invoices the manufacturer directly for their services.

The manufacturer is responsible for meeting all costs of the audits. This includes any follow-up work required to close-out the audit, such as verification audits or desk reviews.

4. How an audit is conducted

An auditor’s role is to systematically and objectively collect and analyse sufficient relevant evidence to make an assessment of the manufacturer’s compliance with the APVMA’s GMP requirements.

Their main objectives are to:

determine the extent of a manufacturer’s compliance with APVMA requirements

Although the auditor may discuss various options for improvements and corrective action, it is the responsibility of the manufacturer to determine the most appropriate course of action to address identified non-conformances.

5. After the audit

Once an Australian manufacturing site has undergone an audit, the auditor provides their report to the manufacturing facility. Audit reports for overseas sites are provided to the manufacturing site or registration holder, whoever commissioned the audit.

The manufacturer should review the audit report and develop a plan to address any identified non-conformances.

The original report must be signed by the manufacturer or their representative and sent to the APVMA along with a completed Response to GMP audit report form within 25 working days of the audit being completed. The form also seeks feedback from the manufacturer about the conduct of the audit.

6. Non-conformances

If non-conformances are identified during the audit, the manufacturer must submit certain information to the auditor before the audit can be closed.

The type of information required will be determined based on the outcome of the audit.

7. Audit closure

The APVMA determines when an audit is officially ‘closed-out’ and provides manufacturers with written advice accordingly.

Before the APVMA can close an audit, the auditor must provide it with written advice confirming all corrective actions arising from the audit have been completed or a satisfactory plan has been approved.

Audit closure notifications also provide the due date for the next audit, according to each manufacturer’s audit schedule.

8. Unofficial audits by GMP consultants

advise on and assist in meeting the requirements of the GMP Code (or equivalent).

Audits for licensing purposes can only be carried out by APVMA-authorised GMP auditors. An auditor cannot perform this task if they have been engaged by the manufacturer on GMP-related consulting matters—other than for licensing or auditing purposes—in the previous three years. This means manufacturers cannot use the report of a consulting audit as evidence of GMP compliance for licensing purposes.

9. Quality assurance under the Manufacturers’ Licensing Scheme

There are a number of ways we maintain a high quality auditing scheme, one being the way we select our auditors. Auditors are selected based on their experience, qualifications and familiarity with the Manufacturing Principles and the Code of GMP. We also conduct training workshops and joint audits, and send APVMA staff to audits as observers.